Celcuity

Celcuity's Revtorpyk Gains FDA Approval for ER+/HER2- Breast Cancer, Faces Launch Delays and Market Scrutiny

Celcuity secured FDA approval for Revtorpyk, a critical second-line treatment for ER-positive, HER2-negative breast cancer patients without PIK3CA mutations. Despite this milestone, Celcuity's shares fell nearly 20% due to an unexpected launch delay to late Q3 2026 and higher-than-anticipated discontinuation rates in the prescribing information, prompting close market observation for this new entrant.